Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)

University of Minnesota (UMN)

Status and phase: Completed; Early Phase 1

Conditions: Hemiparesis

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT01636661

1205M13901

Details and patient eligibility

About

The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.

The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:

1. tDCS will not produce a major adverse event, including seizure activity.
2. No change in paretic or nonparetic hand function or cognitive status will occur.

Full description

Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.

Enrollment: 13 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
2. Hemispheric Stroke or Periventricular Leukomalacia
3. Ages 8-17 years old
4. ≥ 10 degrees of active motion at the metacarpophalangeal joint
5. Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
6. No evidence of seizure activity within the last 2 years.
7. Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.

Exclusion criteria

1. Metabolic Disorders
2. Neoplasm
3. Epilepsy
4. Disorders of Cellular Migration and Proliferation
5. Acquired Traumatic Brain Injury
6. Expressive Aphasia
7. Pregnancy
8. Indwelling metal or incompatible medical devices
9. Evidence of skin disease or skin abnormalities
10. Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups

Transcranial Direct Current Stimulation

Experimental group

Description:

Receiving active tDCS

Treatment:

Device: tDCS

Sham tDCS

Sham Comparator group

Description:

tDCS equipment set to placebo setting.

Treatment:

Device: tDCS